Label: REESES ONETAB ALLERGY AND SINUS- acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 10956-812-01, 10956-812-30 - Packager: REESE PHARMACEUTICAL CO.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 18, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
LIVER WARNING : THIS PRODUCT CONTAINS ACETAMINOPHEN.SEVERE LIVER
DAMAGE MAY OCCUR IF ADULT TAKES MORE THAN 6 DOSES IN 24 HOURS
WHICH IS THE MAXIMUM DAILY AMOUNT, A CHILD TAKES MORE THAN 5 DOSES
IN 24 HOURS , WHICH IS THE MAXIMUM DAILY AMOUNT , TAKEN WITH OTHER
DRUGS CONTAINING ACETAMINOPHEN ,ADULT HAS 3 OR MORE ALCOHOLIC DRINKS
EVERYDAY WHILE USING THIS PRODUCT
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DOSAGE & ADMINISTRATION
Directions
adults and children 12 years of age and older: take 1 caplet every 4 hours as needed.
Do not exceed 6 doses In a 24 hour period or as directed by a doctor
children 6 to under 12 years of age: take 1/2 caplet every 4 hours as needed.
Do not exceed 5 doses In a 24 hour period or as directed by a doctor
children under 6 years of ago: consult a doctor -
DO NOT USE
Do not use _ with any other drug containing acetaminophen (prescription or nonpreescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist _ more than directed _ if you are taking sedatives or tranquilizers without first consulting your doctor _ if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's Disease) or for two weeks after stopping the MAD I drug if are uncertain whether your prescription drug contains an MAOI, consuit a health professional before taking this product
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ASK DOCTOR
Ask a doctor before use if the user has liver damage persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema, cough is accompanied by excessive phlegm (mucus), high blood pressure, thyroid disease, glaucoma, diabetes, heart disease, a breathing problem such as emphysema or chronic bronchitis, difficulty In urination due to enlargement of the prostate gland
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur,
- pain symptoms do not improve after 7 days for adults or 5 days for children orlend to recur
_ cough and cold symptoms do not improve within 7 days or recur
_ symptoms are accompanied by fever that lasts more than 3 days
_ sore throat is severe or persists for more than 2 days
_ new symptoms occur or redness, swelling, rash, persistent headache, nausea or vomiting occur.
These could be signs of a serious condition - PREGNANCY OR BREAST FEEDING
- OVERDOSAGE
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REESES ONETAB ALLERGY AND SINUS
acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-812 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength hypromellose (UNII: 3NXW29V3WO) magnesium silicate (UNII: 9B9691B2N9) magnesium stearate (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape OVAL (CAPLET) Size 17mm Flavor Imprint Code RC;CPE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-812-01 1 in 1 CARTON 1 NDC:10956-812-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/05/2010 Labeler - REESE PHARMACEUTICAL CO. (004172052) Registrant - REESE PHARMACEUTICAL CO. (004172052) Establishment Name Address ID/FEI Business Operations REESE PHARMACEUTICAL CO. 004172052 repack, relabel Establishment Name Address ID/FEI Business Operations CONTRACT PHARMACAL 057795122 manufacture